AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Amoxicillin (UNII: 804826J2HU) (Amoxicillin - UNII:804826J2HU), Clavulanate Potassium (UNII: Q42OMW3AT8) (Clavulanic acid - UNII:23521W1S24)

Available from:

Rebel Distributors Corp.

INN (International Name):

Amoxicillin

Composition:

Amoxicillin 400 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and clavulanate potassium for oral suspension and chewable tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections – caused by β-lactamaseproducing strains of H. influenzae and M. catarrhalis. Otitis Media – caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis – caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections – caused by β-lactamaseproducing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections – caused by β-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While amoxicillin and clavulanate potassium for oral suspension and chewable tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin and clavulanate potassium for oral suspensi

Product summary:

Amoxicillin and clavulanate potassium for oral suspension, USP is supplied as a dry white powder containing: Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 0781-6102-46 ...............................................100 mL bottle Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. NDC 0781-6104-46 ................................................100 mL bottle Amoxicillin and Clavulanate Potassium tablets, USP (chewable) are supplied as: Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg tablets, USP (chewable): Round, pink, cherry-banana flavored tablets embossed "GGN2" on one side and plain on the reverse side. Each tablet contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 0781-1619-66 ..............................Carton of 20 (4 × 5) tablets Amoxicillin and Clavulanate Potassium 400 mg/57 mg tablets, USP (chewable): Round, pink, cherry-banana flavored tablets embossed "GGN4" on one side and plain on the reverse side. Each tablet contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. NDC 0781-1643-66 ............................Carton of 20 (4 × 5) tablets Store tablets and dry powder at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
REBEL DISTRIBUTORS CORP.
----------
AMOXICILLIN AND CLAVULANATE POTASSIUM
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium for oral suspension and chewable tablets and
other antibacterial drugs,
amoxicillin and clavulanate potassium for oral suspension and chewable
tablets should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Amoxicillin and clavulanate potassium for oral suspension and chewable
tablets are an oral antibacterial
combination consisting of the semisynthetic antibiotic amoxicillin and
the β-lactamase inhibitor,
clavulanate potassium (the potassium salt of clavulanic acid).
Amoxicillin is an analog of ampicillin,
derived from the basic penicillin nucleus, 6-aminopenicillanic acid.
The amoxicillin molecular formula
is C
H N O S•3H O and the molecular weight is 419.46. Chemically,
amoxicillin is (2_S_,5_R_,6_R_)-6-
((_R_)-(-)-2-Amino-2-(_p_-hydroxyphenyl)
acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)
heptane-2-carboxylic acid trihydrate and may be represented
structurally as:
Clavulanic acid is produced by the fermentation of _Streptomyces
clavuligerus_. It is a β-lactam structurally
related to the penicillins and possesses the ability to inactivate a
wide variety of β-lactamases by
blocking the active sites of these enzymes. Clavulanic acid is
particularly active against the clinically
important plasmid mediated β-lactamases frequently responsible for
transferred drug resistance to
penicillins and cephalosporins. The clavulanate potassium molecular
formula is C H KNO and the
molecular weight is 237.25. Chemically clavulanate potassium is
potassium (_Z_ )-(2_R_,5_R_)-3-(2-
hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate
and may be represented
structurally as:
Each chewable tablet and each teaspoon (5 mL) of r